BYETTA SUMMARY
BYETTA® (exenatide) is a synthetic peptide that has incretin-mimetic actions and was originally identified in the lizard Heloderma suspectum. BYETTA enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying. Exenatide differs in chemical structure and pharmacological action from insulin, sulfonylureas (including D-phenylalanine derivatives and meglitinides), biguanides, thiazolidinediones, and alpha-glucosidase inhibitors. Exenatide is a 39−amino acid peptide amide.
BYETTA is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control.
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NEWS HIGHLIGHTSMedia Articles Related to Byetta (Exenatide Injection)
6 Deaths Reported From Diabetes Drug Byetta
Source: MedicineNet Autopsy Specialty [2008.08.28]
Title: 6 Deaths Reported From Diabetes Drug Byetta
Category: Health News
Created: 8/28/2008
Last Editorial Review: 8/28/2008
FDA Issues Warning for Diabetes Drug (HealthDay)
Source: Y! Health Diabetes News [2009.11.03]
HealthDay - TUESDAY, Nov. 3 (HealthDay News) -- Reports about possible kidney
problems, including renal failure, in people taking the diabetes drug
exenatide (Byetta) have prompted changes to the drug's prescribing
information, the U.S. Food and Drug Administration said Monday.
FDA Okays Diabetes Drug for First-Line Use, Adds Warning
Source: MedPage Today Endocrinology [2009.11.02]
WASHINGTON (MedPage Today) -- The FDA expanded the indication and prescribing language for the type 2 diabetes drug exenatide (Byetta).
Published Studies Related to Byetta (Exenatide Injection)
Evaluation of exenatide vs. insulin glargine in type 2 diabetes: cost-effectiveness analysis in the German setting. [2009.11]
OBJECTIVES: The objective of this analysis was to determine the cost-effectiveness of exenatide vs. insulin glargine in patients with type 2 diabetes failing to achieve glycaemic control with oral antidiabetic agents, in the German setting, from a third-party payer perspective... CONCLUSIONS: Exenatide was projected to be associated with similar clinical outcomes and increased costs compared with insulin glargine. Analysis of cost-effectiveness from a third-party perspective suggests that exenatide is likely to represent good value for money in the German setting.
Exenatide versus insulin glargine: a cost-effectiveness evaluation in patients with Type 2 diabetes in Switzerland. [2009.08]
OBJECTIVES: To investigate the long-term clinical and economic outcomes associated with exenatide versus insulin glargine as "add-on" treatments to oral therapy in individuals with Type 2 diabetes inadequately controlled with combination oral agents in the Swiss setting... CONCLUSIONS: Exenatide was associated with comparable life expectancy and an improvement in quality-adjusted life expectancy versus insulin glargine over a 35-year time horizon. Based on current standards exenatide would be a cost-effective treatment alternative to insulin glargine in Switzerland for Type 2 diabetes patients inadequately controlled on oral therapy.
Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). [2009.07.04]
BACKGROUND: Unlike most antihyperglycaemic drugs, glucagon-like peptide-1 (GLP-1) receptor agonists have a glucose-dependent action and promote weight loss. We compared the efficacy and safety of liraglutide, a human GLP-1 analogue, with exenatide, an exendin-based GLP-1 receptor agonist... INTERPRETATION: Liraglutide once a day provided significantly greater improvements in glycaemic control than did exenatide twice a day, and was generally better tolerated. The results suggest that liraglutide might be a treatment option for type 2 diabetes, especially when weight loss and risk of hypoglycaemia are major considerations. FUNDING: Novo Nordisk A/S.
Exenatide exhibits dose-dependent effects on glycemic control over 12 weeks in Japanese patients with suboptimally controlled type 2 diabetes. [2009.06]
This study assessed the dose-dependent efficacy and safety of exenatide over 12 weeks in Japanese patients with type 2 diabetes suboptimally controlled despite therapeutic doses of sulfonylurea (SU), SU plus biguanide, or SU plus thiazolidinedione. Patients were randomly assigned to placebo (N = 40), 2.5 microg (N = 38), 5 microg (N = 37), or 10 microg (N = 38) exenatide administered subcutaneously twice daily (BID)...
One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. [2009.05]
CONCLUSIONS: Exenatide significantly improves beta-cell function during 1 year of treatment compared with titrated insulin glargine. After cessation of both exenatide and insulin glargine therapy, beta-cell function and glycemic control returned to pretreatment values, suggesting that ongoing treatment is necessary to maintain the beneficial effects of either therapy.
Clinical Trials Related to Byetta (Exenatide Injection)
Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1) [Active, not recruiting]
The purpose of this study is to examine the effects of exenatide long-acting release (LAR) on
glucose control and safety in subjects with type 2 diabetes mellitus managed with diet
modification and exercise and/or oral antidiabetic medications.
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes [Completed]
The primary purpose of this study is to assess the anti-exenatide-antibody response to
exenatide re-exposure as measured by anti-exenatide antibodies and incidence of
treatment-emergent allergy and hypersensitivity reactions following a period of treatment
interruption, in patients previously exposed to exenatide.
Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) [Active, not recruiting]
This long term, placebo-controlled trial is intended to assess the efficacy and safety of
exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with
oral antidiabetic(s) but not well controlled.
A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes [Completed]
As exenatide slows the rate at which materials leave the stomach, it is likely to alter the
rate of intestinal absorption of oral drugs when administered within a certain timeframe
relative to exenatide. In addition, the residence time within the stomach of other medication
may be prolonged and data from this study will help assess the change in residence time in
the presence of therapeutic doses of exenatide. This study will also evaluate the
relationship between blood levels of exenatide and parameters measuring rate of stomach
emptying.
Safety and Efficacy of Exenatide as Monotherapy [Completed]
This Phase 3 trial is designed to compare the effects of twice-daily exenatide and
twice-daily placebo with respect to glycemic control in drug-naive patients with type 2
diabetes treated with diet and exercise.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 5 ratings/reviews, Byetta has an overall score of 7.40. The effectiveness score is 8.40 and the side effect score is 7.20. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Byetta review by 42 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | diabetes |
| Dosage & duration: | | 10mcg (dosage frequency: 2x daily) for the period of 2 years |
| Other conditions: | | narcolepsy |
| Other drugs taken: | | provigil | | |
Reported Results |
| Benefits: | | helped to stay awake, without the side effects that I had when I used to take dexedrine, like jittery, agitation, dry mouth |
| Side effects: | | There really weren't any side effects like those described above from dexedrine. |
| Comments: | | 100-150 mg a day, 100mg taken in the am, 50mg in pm (if needed) to help with daytime sleepiness, caused by narcolepsy. I usually do not take the afternoon dose unless I feel really tired and nervous about driving. |
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| | Byetta review by 51 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Diabetic |
| Dosage & duration: | | 10 mcg (dosage frequency: twice daily) for the period of 4 years |
| Other conditions: | | blockage & allergies |
| Other drugs taken: | | metformin, allegra, lipator, tricor | | |
Reported Results |
| Benefits: | | This slows the sugar going into my system so that my body can use most of my own insulin to process the sugar. It is to be taken along with the metformin. It has helped control my blood sugar very well. |
| Side effects: | | It can sometimes cause nausea. At the start of treatment it was bad but now it only happens if I miss a dose then the next one will cause nausea. The first couple of months I saw a very slight drop in weight but I am not sure if the Byetta caused this. |
| Comments: | | I take a shot before my first meal and last meal each day. It is a very easy shot to give to myself but it is easy to forget if I eat out or if I am traveling. |
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| | Byetta review by 56 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | obesity and diabetes |
| Dosage & duration: | | 5mcg and 10mcg (dosage frequency: 2 times per day) for the period of 2 years |
| Other conditions: | | none |
| Other drugs taken: | | luvox, norvasc, metformin | | |
Reported Results |
| Benefits: | | I initially had severe cramping and nausea, but I continued under doctor's orders, I only lost about 20 pounds, tops. I now have a larger host of problems I believe were started with this medication. I have not used in 3 years. |
| Side effects: | | Severe cramping, headaches, incredible nausea, muscle cramps, vomiting blood (not once but on 2 occasions due to doctor's orders). I now am facing something wrong with my digestive tract and no doctor has been able to figure out what is wrong. Since this is the area where the medication was injected, and only there, I believe that the byetta is the perfect suspect. Now, if I could only find a doctor that will listen to me. The count is 5 and still increasing. Recently, I lost 4 pounds in 3 days!!!! This is not normal! |
| Comments: | | I was to inject the said amount into the abdominal (below the waist, above the pelvic bone) before breakfast and lunch. The amount was changed when the medical professional I was having treat me decided to increase the dosage, and with terrible results (I was vomiting blood and could not eat or even drink water - I couldn't even stand the smell of food). I wish I had never heard of Byetta!!!!!! |
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Page last updated: 2009-11-03
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